Tera Lumbar Interbody Fusion System (Various PNs)

The Tera Lumbar Interbody Fusion System is an intervertebral body fusion device made of titanium alloy (Ti-6Al-4V ELI) manufactured using laser powder bed fusion additive manufacturing. It is designed for lumbar interbody fusion at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease and up to Grade I spondylolisthesis who have failed at least six months of non-operative treatment. The device features a solid core with a layered porous lattice surface structure to facilitate bone in-growth and is available with an optional hydroxyapatite coating.

The Tera system has identical indications, design, similar dimensions, and identical materials (Ti-6Al-4V ELI) as the primary predicate Align device (K221535). Key differences include updated implant cage inserter interface designs, additional implant heights and lordosis offerings, expanded instrument options, optional hydroxyapatite coating, and a change to a new additive manufacturing supplier that is identical to additional predicate K243386. The optional HA coating matches the material used in additional predicate K222561.

ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static and dynamic axial compression and shear testing), ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Compression, and ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (including tensile testing, microstructure assessment, and chemical composition assessment).

Substantial equivalence is established through mechanical performance testing demonstrating the worst-case subject device configuration performs equivalently to predicate devices across all tested parameters (static/dynamic compression and shear, subsidence). The design, materials, indications, and mechanism of action are identical to the primary predicate K221535. While the manufacturing supplier changed, testing confirmed no new or increased risks from this change, and the new supplier is already qualified through additional predicate K243386. The optional enhancements (additional sizes, HA coating) do not raise new safety or effectiveness concerns as they use proven materials and design principles from existing predicates.